A Dose Escalation Study of STA-9090 and Docetaxel in Patients With Solid Tumors

Solid Tumor Malignancies Clinical Trial

Official title:

A Phase 1, Pharmacokinetic Study of STA-9090 in Combination With Docetaxel in Subjects With Advanced Solid Tumor Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01183364
• Other study ID #: 9090-07
• Status: Completed
• Phase: Phase 1
• First received: August 11, 2010
• Last updated: September 18, 2014
• Start date: July 2010
• Est. completion date: May 2013

Study information

• Verified date: September 2014
• Source: Synta Pharmaceuticals Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is an open-label, Phase 1, dose-escalation study to determine the recommended doses of STA-9090 (ganetespib) and docetaxel for the treatment of subjects with solid tumor malignancies. The safety and tolerability of the treatment will also be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must have histologically confirmed metastatic or unresectable malignancy with evidence of progression

• If subject has been treated with docetaxel, must have evidence of persistent or progressive disease

• Measurable disease per RECIST

• CNS metastases are permitted if treated and radiographically and clinically stable for 4 weeks prior to first dose

• ECOG status less than or equal to 2

• Life expectancy greater than 3 months

• Adequate hematological, hepatic and renal function as defined by protocol

• Willingness and ability to comply with study requirements

• Female subjects of childbearing age must have a negative pregnancy test at study entry

• Female subjects of child bearing age and males must agree to use adequate contraception as defined in the protocol

Exclusion Criteria:

• Prior chemotherapy or investigational agents within 3 weeks or 5 times the agent's half life, whichever is shorter prior to first dose

• Radiotherapy within 2 weeks of first dose

• Surgery, radiotherapy or ablative procedure to the only area of measurable disease

• Major surgery within 4 weeks of first dose

• Poor venous access that would require an indwelling catheter for study drug administration

• History of severe allergic or hypersensitivity reactions to STA-9090 or docetaxel or their diluents or excipients

• Baseline QTc >470 msec or previous history of QT prolongation while taking other medications

• Peripheral neuropathy > Grade 1

• Ventricular ejection fraction less than or equal to 55% at baseline

• Treatment with chronic immunosuppressants. However subjects may receive steroids for stable CNS metastases

• Women who are pregnant or lactating

• Uncontrolled intercurrent illness

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor Malignancies

Intervention

Drug:
• STA-9090 (ganetespib) with Docetaxel
One treatment cycle will consist of weekly treatments for 2 weeks followed by a 1-week rest period. Treatment cycles will be repeated every 3 weeks. STA-9090 will be administered on Days 1 and 8 of each cycle and docetaxel will be administered on Day 1 of each cycle. Each agent will be administered as a separate 1-hour intravenous infusion.

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Synta Pharmaceuticals Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of STA-9090 (ganetespib) and docetaxel combination	The number of adverse events will be used as a measure of safety	June 2011	Yes
Secondary	Pharmacokinetics	Pharmacokinetics of STA-9090 (ganetespib) and Docetaxel. This includes concentrations of these drugs in patients' blood at various protocol-specified times relative to the time of dose administration. These will be summarized by parameters including maximum concentration, total exposure and how fast the patient's body gets rid of the drug (known as Cmax, AUC, t1/2, respectively).	June 2011	No